KemPharm Announces FDA Approval of sNDA for Two Additional Strengths of Apadaz (4.08 mg benzhydrocodone/325 mg APAP and 8.16 mg benzhydrocodone/325 mg APAP)
CORALVILLE, Iowa, Jan. 07, 2019 (GLOBE NEWSWIRE) -- KemPharm, Inc. (NASDAQ:KMPH), a specialty pharmaceutical company focused on the discovery and development of proprietary prodrugs, announced today that the U.S. Food and Drug Administration (FDA) has approved a Supplemental New Drug Application (sNDA) for two additional strengths of Apadaz, an immediate release (IR) combination of KemPharm’s prodrug, benzhydrocodone, and acetaminophen (APAP). The approval of these new dosage strengths, 4.08 mg benzhydrocodone/325 mg APAP and 8.16 mg benzhydrocodone/325 mg APAP, follows the New Drug Application (NDA) approval on February 23, 2018 of the 6.12 mg benzhydrocodone/325 mg APAP dosage strength of Apadaz.
“When commercializing a new product in a very large market, such as with Apadaz, minimizing potential barriers for both physicians and health plans is paramount to facilitating the potential replacement of other hydrocodone/APAP products currently available. We believe the timing of this sNDA approval is great news for a second half 2019 launch with our commercial partner, KVK-Tech,” said Travis Mickle, Ph.D., KemPharm’s President and Chief Executive Officer. “We believe the sNDA approval of the two additional strengths of Apadaz enhances the marketability, and ultimately the acceptance of the product, by offering physicians maximum flexibility when prescribing the product,” Dr. Mickle concluded.
Apadaz was developed from KemPharm’s proprietary LAT™ (Ligand Activated Therapy) platform technology and is intended for the short-term (no more than 14 days) management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Apadaz is differentiated from other prescription opioids as it is the first FDA-approved product to contain a prodrug of hydrocodone. A prodrug is chemically inert, or inactive, on its own. When ingested, enzymes in the gastrointestinal tract cleave the ligand from the prodrug (benzhydrocodone) and release the parent drug (hydrocodone), which can then exert its therapeutic effect. The final approved product labeling for Apadaz includes these and other data points but concludes that the overall results of the clinical program did not demonstrate abuse-deterrence by current measurement standards.
The approval of Apadaz via the 505(b)(2) pathway was based in part on pharmacokinetic studies with Vicoprofen®, Ultracet®, and Norco® in which Apadaz demonstrated exposure to hydrocodone and acetaminophen (APAP) that is expected to result in therapeutic effects equivalent to currently approved immediate-release hydrocodone/APAP combination products when administered orally as intended.
KemPharm is a specialty pharmaceutical company focused on the discovery and development of proprietary prodrugs to treat serious medical conditions through its proprietary LATTM (Ligand Activated Therapy) platform technology. KemPharm utilizes its proprietary LATTM platform technology to generate improved prodrug versions of FDA-approved drugs in the high need areas of ADHD, pain and other central nervous system disorders. KemPharm’s co-lead clinical development candidates are KP415 and KP484, both based on a prodrug of methylphenidate, but with differing extended-release/effect profiles for the treatment of ADHD. In addition, the company has received FDA approval for APADAZ®, an immediate-release combination product candidate of benzhydrocodone, a prodrug of hydrocodone, and acetaminophen. The company is also advancing KP201/IR, an acetaminophen-free immediate-release formulation of the company’s benzhydrocodone prodrug candidate. Both APADAZ® and KP201/IR are intended for the treatment of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. For more information on KemPharm and its pipeline of prodrug product candidates visit www.kempharm.com.
Caution Concerning Forward Looking Statements:
This press release may contain forward-looking statements made in reliance upon the safe harbor provisions of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements include all statements that do not relate solely to historical or current facts, including statements about launching APADAZ with KVK-Tech in the second half of 2019, expected physician adoption, prescribing benefits and marketability of APADAZ, and can be identified by the use of words such as “may,” “will,” “expect,” “project,” “estimate,” “anticipate,” “plan,” “believe,” “potential,” “should,” “continue” or the negative versions of those words or other comparable words. Forward-looking statements are not guarantees of future actions or performance. These forward-looking statements are based on information currently available to KemPharm and its current plans or expectations and are subject to a number of uncertainties and risks that could significantly affect current plans. Risks concerning KemPharm’s business are described in detail in KemPharm's Annual Report on Form 10-K for the year ended December 31, 2017, and KemPharm’s other Periodic and Current Reports filed with the Securities and Exchange Commission. KemPharm is under no obligation to (and expressly disclaims any such obligation to) update or alter its forward-looking statements, whether as a result of new information, future events or otherwise.
Posted: January 2019
- FDA Approves Apadaz (benzhydrocodone and acetaminophen) for the Short-Term Management of Acute Pain - February 23, 2018
- FDA Issues Complete Response Letter for Apadaz New Drug Application - June 13, 2016
- Statement Regarding FDA Advisory Committee Meeting on KemPharm’s Abuse-Deterrent Product Candidate Apadaz - May 5, 2016
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